1996 IOM Report on Contraceptive Research

1
1996 IOM Report on Contraceptive
Research
Development A Summary

• Allan Rosenfield
• New Frontiers in Contraceptive Research
• Institute of Medicine
• July 15, 2003

2
Funding Support

• Rockefeller Foundation
• Andrew W. Mellon Foundation
• NICHD
• USAID
• CONRAD

3
Study Questions
IOM Study on Contraceptive RD

• Is there a need for new contraceptives and, if
  so, is there a market?
• If the field of contraceptive RD has lost
  energy, are there new prospects in the sciences
  that could reenergize it?
• Given such prospects, would they be sufficient to
  accomplish the revitalization?
• Is there potential for public private
  partnerships?

4
Study Objectives
IOM Study on Contraceptive RD

• To identify new leads for the next generation of
  contraceptives
• To consider ways to attract private sector
  involvement, including pharmaceutical industry
  and biotechnology companies

5
Study organized around 2 major activities
IOM Study on Contraceptive RD

• Workshop on prospects of the science underlying
  the development of new contraceptives - December
  1994
• Workshop on the opportunities, challenges , and
  strategies for private-sector participation in
  contraceptive research and development - May 1995

6
Framework for Committees Deliberations
IOM Study on Contraceptive RD

• Woman-Centered Agenda
• Spermicides/Microbicides
• Menses inducers and monthly methods
• Male contraceptives

7
Global Indicators of Need Market Demand
IOM Study on Contraceptive RD

• Unintended pregnancy (40-60)
• Abortion 40-50 M (approx. 20 M unsafe)
• Unmet need 120 200 M women
• Growing numbers of adolescent women
• Contraceptive side effects, failure
  discontinuation
• Sterilization

8
Contraceptive Developments 1960-1996
IOM Study on Contraceptive RD

• Major breakthroughs, 1960 OCs and IUDs
• Succeeding years method improvements
• Better IUDs
• Better OCs
• Newer ways to deliver hormonal methods for women
• Anti-progestins only significant new breakthrough
• Possible new approaches if newer molecular and
  cellular basic science tools applied

9
Obstacles to Contraceptive Research

• Economic
• Regulatory
• Liability
• Political - Ideological

10
Major Recommendations
IOM Study on Contraceptive RD

• New contraceptives are needed and there is a
  market if developed
• A womens centered agenda should be focus

11
Major Recommendations Research
IOM Study on Contraceptive RD

• Work with genes whose products are truly specific
  vs. central mechanism of action
• Methods acting as chemical or physical barriers
  to conception and STD/HIV transmission
• Menses-inducers and once-a-month methods targeted
  at different points in menstrual cycle
• Methods for males to expand their contraceptive
  choices and responsibility

12
Major Recommendations Financial
IOM Study on Contraceptive RD

• RD on anti- and post-implantation methods as a
  priority for funders (smaller firms and nonprofit
  organizations) who are not constrained by
  controversy
• Continued public sector support for innovative
  basic research in reproductive biology and
  applied research to bring best leads to fruition

13
Major Recommendations Financial
IOM Study on Contraceptive RD

• Support for Consortium for Industrial
  Collaboration in Contraceptive Research (CICCR),
  whose purpose is to catalyze funding for
  feasibility studies and matching industry support
  potentially high-payoff mechanism for sponsor
  investment
• Expand coverage by public- and private-sector
  third party payers for contraceptive services
• Multilateral support for an extension of Global
  Contraceptive Commodity Program to create
  incentives for developing new contraceptives

14
Major Recommendations Legal/Regulatory
IOM Study on Contraceptive RD

• Enact Government Standards Defense allowing
  defendant manufacturers to assert the honest open
  compliance with FDA requirements, which would
  provide some liability shelter
• Immediate FDA attention to generation of clear
  guidelines for manufacturers for development of
  vaginal microbicides and spermicides

15
Major Recommendations Information, Education,
Communication
IOM Study on Contraceptive RD

• Significant effort toward balanced, accurate,
  intelligible packaging to
• Correct current lack of appropriate product
  information for providers and consumers
• Catalyze dialogue across sectors and interest
  groups

16
Impact of the Report
IOM Study on Contraceptive RD

• Microbicide Research
• More than 90 million committed to research
• Population Council, CICCR, new IPM
• Donors Gates, Rockefeller, World Bank, DFID
• Male Contraception Research
• Public private partnership
• Focus on post-testicular methods
• Renewed interest in hormonal methods

17
Impact of the Report (cont.)
IOM Study on Contraceptive RD

• Monthly methods
• Mifepristone studies in China
• Emergency contaception
• Luteal contraception
• Post-implantation abortifacient
• Multiple studies of mifepristone, misoprostol and
  methotrexate
• Renewed interest of pharmaceutical industry,
  although much still needed

18
The Challenge to the New Committee
IOM Study on Contraceptive RD

• Continue efforts to involve basic molecular
  science in the field
• Identify new leads, particularly those without
  systemic side effects.
• Expand funding support from private foundations,
  government and industry